Steroids are one of the pillars of immunosuppression for kidney transplant patients but their use is associated with a high rate of complications. Withdrawal of steroids reduces some metabolic and cardiovascular complications, but it may increase the risk of acute rejection. However, little is known about whether steroid withdrawal is associated with the generation of anti-HLA donor-specific antibodies (DSA) and the relation between DSA and clinical and histological data. The aim of this study is to compare the incidence of de novo anti-HLA DSA in stable kidney transplant patients after withdrawing the steroids 3 months after the transplantation as compared with patients who continue with steroids. The hypothesis is that steroid withdrawal will increase the presence of de novo anti-HLA DSA in stable kidney transplant patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
Withdrawal of steroids
Continuation of steroids
Vall d Hebron Hospital
Barcelona, Spain
Bellvitge Hospital
Barcelona, Spain
Carlos Haya Hospital
Málaga, Spain
Canarias University Hospital
Santa Cruz de Tenerife, Spain
Dr. Peset Hospital
Valencia, Spain
Cases of Kidney Transplant Patients With DSA
Measurements of DSA at baseline, and at 3, 6, 12, 18 and 24 months
Time frame: 24 months
Mean Score on the Protocol Biopsies in the Two Treatment Groups
Measurement at 24 months according to the Banff classification. The Banff Classification of Allograft Pathology is an international consensus classification for the reporting of biopsies from solid organ transplant. The scale ranges from 0 to 3, 3 being the worst.
Time frame: 24 months
Number of Participants With Acute Rejection Lesions
Patients with acute rejection lesions (including subclinical rejection) at 24 months according to Banff classification
Time frame: 24 months
Incidence of Diabetes Mellitus
Incidence of diabetes mellitus after kidney transplant in both groups at 1, 2, 3, 4, 6, 9, 12, 18 and 24 months
Time frame: 24 months
Lipid Profile
Lipid profile after kidney transplant in both groups at 24 months
Time frame: 24 months
Blood Pressure
Blood pressure after kidney transplant in both groups at 24 months
Time frame: 24 months
Renal Function
Renal function after kidney transplant in both groups at 24 months measured according to the creatinine (mg/dL) concentrations
Time frame: 24 months
Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups
The Basle scale was used to assess adherence (BAASIS questionnaire) to immunosuppressive therapy.
Time frame: At 24 months
Patient Survival
Patient survival after kidney transplant in both groups
Time frame: 24 months
Graft Survival
Graft survival after kidney transplant in both groups
Time frame: 24 months
Renal Function
Renal function after kidney transplant in both groups at 24 months measured according to the proteinuria (mg/24 h) concentrations
Time frame: 24 months
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